call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
Clinical Logistics Trial
1. Register by September 11th
Presents and SAVE UP TO $1,347
Clinical Trials
Logistics
TM
December 7-9, 2009
Philadelphia, PA
Maximizing Efficiency, Safety and Regulatory
Compliance Within your Clinical Supply Chain
Our Exceptional
Speaker Faculty
Includes
Representatives From:
• Sanofi-Aventis
• Pfizer
Discover and Learn Best Practices and Strategies Including: • AstraZeneca
• Overcoming key inefficiencies within your • Building an effective risk management • Merck
clinical supply chain strategy into your clinical trials logistics
• Understanding how and why global clinical • Avoiding common mistakes and pitfalls • GlaxoSmithKline
supplies effect enrolment for clinical trials logistics challenges in
emerging countries
• Genzyme
• Developing and maintaining a successful and
safe vendor relationship for your clinical • Addressing and overcoming challenges of • Takeda
supplies storage and transportation of your clinical
• Complying with US customs standards for supplies • Human Genome
importing clinical supplies Sciences
• Schering Plough
Additionally, don’t miss the New Clinical Data Management
Focus Master Class Day covering: • Celgene
• Evaluating the risk of transitioning from • Using clinical trial data effectively to better • Gilead Sciences
spreadsheet models to a sophisticated manage clinical trials supply
clinical supply forecasting systems • Department of
• Understanding strategies for predictive
• Forecasting Clinical Trial Supply Demand Data patient recruitment and supply modeling Homeland Security
accurately to reduce cost to ensure successful completion of clinical trials
• Food & Drug
Sponsor: Media Administration
Partners:
www.clinicaltrialslogistics.com
2. A special thanks to our
Executive Advisory Board
Clinical T ials
r Mary Driver
Vice President, Global Head, Clinical
Supply Chain
Pfizer
Logistics
Dear Colleagues,
TM
Karl Kussow
Manager, Quality and Validation
FedEx Custom Critical
Rich Ellinger
Director, Global Marketing and
Business Development
In today’s drug development clima Tegrant Corporation
te, clinical supply professionals face
These include adhering and complyin a unique set of challenges. Clifford W. Wyllie
g with stringent regulations, cost-
distribution, using specialized temp effective/ validated Vice President, Bio-Pharma Healthcare
erature packaging and monitorin
research labs/hospitals and many g devices, shipping to and from Services
more. This timely conference will
unique solutions to your organizat provide a series of novel and Cavalier Logistics
ion’s clinical supply challenges.
Mike Meakin
At this year’s Clinical Trials Logistics
conference, you will hear 17+ in-de Vice President, Quality Assurance &
examples including: pth sessions and case study
• Building a
Regulatory Affairs, Life Science &
supply chain project management Healthcare EMEA
• Creating effic core competency
iencies within your clinical supply DHL Supply Chain
• Automating chain through product pooling
clinical trials labeling in complian
• Defining impo ce with FDA 21 CFR Part 11 Alex Guillen
rt and export regulations, procedur
studies es and strategies to run successfu Chief Executive Officer
l global clinical
• Due diligence
in emerging markets Escort Cold Chain Solutions SA
• Deciding on
internal vs. external clinical manufac Lisa Ortega
• Effectively turing for your organization
managing domestic and global depo Manager, Clinical Supply Mgmt
• Addressing ts for the efficient distribution of
challenges of storage and transport clinical supplies Systems & Planning
• Overcoming ation for your clinical supplies
packaging challenges for the shipm Allergan
ent of your clinical supplies
Additionally, attend our Pre-Confe Eddie Montoya
rence Workshops or Clinical Data Director, Clinical Supply Chain
which include sessions and case-stud Management Master Class Day
• The effective
y examples on: Fisher Clinical Services
use of IVRS in clinical trials managem
• Transforming ent Donald L. Nolde
your clinical supply chain to acco
• Best practices mmodate adaptive trials
for data management associated Vice President, Sales & Marketing
clinical materials with the distribution of temperatu Cold Chain Technologies
re-sensitive
• Optimization
of capacity planning, resource alloc Robert M. Zawacki
trials ation and scheduling for portfolio
of clinical Associate Director, Drug Supply
Management
Benefit from industry presentations
from AstraZeneca, Merck, Pfizer, Wyeth
Plough, Genzyme, Takeda, Human GlaxoSmithKline, Schering
Genome Sciences, and many more
CRO industry experts. This conferen pharmaceutical, biotech and Vladimir Shnaydman
ce promises to be a networking and
leaving you with new ideas and solut discussion-filled event President
ions to help you maximize your clinic ORBee Consulting
al supply chain.
We look forward to seeing you in Karl Schlenker
Philadelphia in December!
Vice President, Sales and Marketing
Best Regards, Minnesota Thermal Science
Michael Colacino
active and
P Highly inter
.S Director, Clinical Manufacturing
e-confer ence Genzyme Drug & Biomedical R&D
Simon Curtis informative pr
e pages 3-4
Vladimir Anisimov
Conference Director
PharmaIQ
workshops! Se Director, Research Statistics Unit
GlaxoSmithKline
for details Gerhard Fortwengel, MPH
Director, Head of Quality Systems
Actelion Pharmaceuticals
Vildan Kortan
Who Will You Meet At The Conference? Worldwide Director, Clinical Supplies
Logistics
CSO’s, Vice Presidents, Directors, Heads & Managers from Pharmaceutical, Biotech and CRO’s specializing in: Bristol Myers Squibb
• Clinical Supply Operations • Regulatory Affairs Arminda Montero
• Clinical Trials Logistics • Quality Assurance/Quality Control Distribution QA Program Manager,
Global Pharmaceutical Operations
• Clinical/Investigational Supplies • Import-Export Trade Compliance Abbott
• Shipping and Distribution • Project Management Matty Toomb
• Clinical Labeling/Packaging • Clinical Research/Planning Vice President, Sales & Marketing
American Thermal Instruments
• Clinical Trials Material Management • Drug Supply Management
Mike Lewis
• Clinical Supplies Manufacturing • Formulation Development Scientists Manager, Business Development
• Clinical Data Management involved in CTM product development Sentry BioPharma Services, Inc.
• Clinical Quality Assurance/Quality Control
2 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
3. Pre-Conference Workshops
Monday, December 7, 2009
9:00am – 11:30am Registration 8:30am Morning Coffee Included
A Optimization of Capacity Planning, Resource Allocation and Scheduling for Portfolio of Clinical Trials
Efficient capacity planning and resource allocation is becoming a hot • How to identify resource bottleneck
topic for biopharmaceutical companies and Clinical Research • How to reallocate resources due to prioritization or cancellation of
Organizations (CRO) due to increasing pressure to reduce cost of drug clinical trials
development. It is critical for many clinical organizations to find a better • How to calculate understaffing risk
approach to increase effectiveness in resource capacity planning in clinical
process, especially for multiple clinical trials. Developing and using How you will benefit:
powerful tools which allows to optimize resource capacity planning, • How to schedule new clinical trials to maximize manpower and budget
allocate resources (both manpower and budget) optimally between capacity in biopharmaceutical company?
planned and ongoing clinical trials. This technique can save up to 30% • How to “pack” maximum number of clinical trials in different
by uncovering better resource allocation solutions. therapeutic areas to maximize capacity utilization (for CROs) across
employee roles
What you will learn: • How to optimize capacity planning across portfolio of clinical trials using
• How to apply optimization technology to capacity planning in ORBee proprietary tool
biopharma
• How to derive workload demand and supply (overview) on a role level
Your Workshop Leader:
• How to optimize capacity planning and resource allocation across
Vladimir Shnaydman, PhD, President, ORBee Consulting
portfolio of clinical trials for both biopharma companies and CROs
12:00m – 2:30pm Registration 11:30am Lunch Included
B Quality and Efficiency for Cost & Temperature Controlled Transportation
The workshop will facilitate a discussion of considerations for choosing a How you will benefit:
transportation method, including international regulations, shipping Through case studies of real-life examples and interactive exercises, you
environments, and the strengths and weaknesses of available will understand how transport systems can be designed to significantly
temperature control options for air and ground transport. reduce or eliminate common problems in domestic US and international
The group will discuss solution options and criteria for designing best air transport. You will gain an appreciation for the relative costs and
practice transportation systems and procedures that appropriately blend benefits of achieving your transportation objectives within the framework
the needs of your product, your business, and available services. We will of your GDP requirements and discuss how to minimize those costs while
also explore the effectiveness of various choices by considering case maintaining safe transport requirements.
studies for both ground and air transport. • Improve your ability to implement high quality, secure, and cost-
effective transportation
What you will learn: • Enhance your ability to apply industry and governmental guidance on
Gain insight into carrier quality systems for both standard transportation Good Distribution Practices in your transportation plans
and temperature control including: • Increase your understanding of how to effectively work with your
• Strategies for implementing best practices for achieving high quality carrier to maximize the quality, consistency, and economy of your
and safety in both air and ground transport shipping lane
• Effective procedures to address transport risk issues
• Decision making factors for evaluating cost-effective transportation Your Workshop Leader:
strategies for cold chain Speaker to be confirmed shortly. Please check
www.clinicaltrialslogistics.com for additional information
3:00pm – 5:30pm Registration 2:30pm
C Integrating Technology within Your Clinical Supply Chain
Like all industries, clinical supplies must deal with the constant need for How you will benefit:
improvement in terms of more efficient and innovative processes. Within • Discover factors affecting global distribution that sponsor companies
this context, many pharma and biotech companies now expect “joined should take into account of when
up thinking” - experts and systems in different disciplines working in • Examine the structure of software applications for forecasting and how
tandem to deliver clinical supplies as efficiently as possible. This workshop they can be used effectively within a trial
examines the key factors in today’s market for successful supply delivery, • Evaluate the benefits of drug pooling strategies using detailed case
powered by effective supporting technologies studies
• Understand how clinical supply and IVR staff can work together in an
What you will learn: integrated fashion to enhance the delivery of supplies
• Managing an expanding global clinical supply network • Explore the pitfalls of a fragmented supply chain
• Improving the supply chain for existing technology
• Integrating project management Your Workshop Leader:
Speaker and sponsorship opportunities available: Please contact
Simon.Curtis@iqpc.com for more information
3 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
4. Pre-Conference Clinical Data
Management Master Class Day
Monday, December 7, 2009
8:45 Registration and Coffee 12:10 Transforming Your Clinical Supply Chain to Accommodate
Adaptive Trials
9:30 Welcome Address and Chairperson’s Opening • Understanding how adaptive trials will impact on CTS
Remarks • Adjusting current procedures to facilitate adaptive trials
• Ensuring flexibility in the supply chain to support adaptive trial design
9:40 Benefits of Using a Sophisticated Clinical Supply Eddie Montoya
Forecasting System: Case Studies Director, Clinical Supply Chain
• Exploring realized benefits of using a clinical supply forecasting Fisher Clinical Services
solution (Subject to final confirmation)
• Discussing a cost benefit analysis to your organization
• Discussing past experience with spreadsheets and identifying
12:50 Networking Luncheon
potential limitations
• Uncovering potential transition problems: E.g. missing doses in
1:50 Best Practices for Data Management Associated with
patients leading to reducing time to market on drug products Distribution of Temperature-Sensitive Clinical Trial Materials
• Understanding the benefits of enabling technology and how
• Understanding regulatory and standards-based guidance for temperature
forecasting models can bridge the gaps inherent to a spreadsheet sensitive clinical trial material presents many unique challenges
model • Examining complex and remote distribution channels to collect, store and
Buz Hillman retrieve critical time and temperature data
Manager, Clinical Supplies Forecasting & Infrastructure, Centocor • Overview of the global regulatory environment and reviews proven practices
Johnson & Johnson for collecting, managing and retrieving time and temperature data
• Identifying opportunities for improving current practices with new
10:20 Panel Discussion: Accurately Forecasting Clinical Trial applications for existing technologies
Supply Demand Data to Reduce Cost * Speaker and sponsorship opportunities available: Please contact
• Understanding why demand forecasting is critical for your Simon.Curtis@iqpc.com for more information
organization
• Discussing novel and effective forecasting tools and techniques 2:30 Effective Use of Clinical Trial Data to Better Manage
• Identifying best practices in forecasting clinical trials supply Clinical Trial Supply
requirements • Discussing Gilead case study: Successfully using up-to-date IVR data
Panelists: • Forecasting the Clinical Trial supply
• Utilizing existing and past data for predicative modeling
Lawrence Florin
• Managing drug supply by real time data from forecast models
Director, Clinical Outsourcing
• Patient enrolment used as a key performance indicator for Clinical Trial
AstraZeneca
forecasting
Mike Dallman
Adrian Hsing
Associate Director, Clinical Supplies
Director of Clinical Data Management
Cerexa
Gilead Sciences, Inc.
11:00 Morning Networking Break
3:10 Predictive Patient Recruitment and Supply Modeling to
11:30 The Effective Use of IVRS in Clinical Trial
Ensure Successful Completion of Clinical Trials
• Uncovering the main sources of uncertainty and appropriate metrics for
Management measuring success
• Understanding the general aspect of using IVRS • Modeling and predicting recruitment at the initial and interim stages
• Weighing up the pros and cons of using IVRS for your clinical • Examining adaptive adjustment of recruitment and number of clinical
supplies
• Discussing effective ways of how IVRS can be managed
centers at any interim time
• Evaluating study performance and site productivity
• Examining case study simulation/modeling examples of clinical trial
• Predictive modeling for drug supply
supplies
Valerii Fedorov
Nirav Shah
Head of Research Statistics Unit
Senior Manager, IMSC
GlaxoSmithKline
Celgene Corp.
3:50 Chairpersons Closing Remarks and End of Master Class
About our Sponsors
FedEx Custom Critical offers a complete array of surface and air • Global distribution of temperature controlled trial medication, vaccines & CTM
solutions to safely and securely ship temperature-sensitive products. • Temperature control monitoring for ambient, 2-8C and frozen products to maintain
You can choose from exclusive-use vehicles with integrity of supplies
temperaturecontrolled cargo boxes to airfreight solutions utilizing temperature-controlled • Advice on packaging materials and provision of containers for global transportation
air containers. With our Temp-Assure Validated services, you also receive hard-copy • Refrigerated trucking services
documentation of the temperature inside the vehicle or container throughout transport. • Customs brokerage accelerating clearance
This assists our pharmaceutical customers with their compliance needs through a Website: www.marken.com
documented audit trail of their productsÅf temperature throughout the shipping process.
FedEx Custom Critical services are available 24/7/365 with surface solutions throughout World Courier has set the benchmark for worldwide time &
the U.S. and Canada and air solutions across the globe. Website: temperature sensitive transportation. We remain the only specialist
www.customcritical.fedex.com courier company with its own global company network .Each office ISO 9001 certified
with the same operating standards dedicated to treating every shipment on an individual,
Marken is one of the leading suppliers of cold-chain logistics for priority basis. World Courier is utilized in approximately 80% of the world’s clinical trials
clinical supplies worldwide. Temperature-control during the handling, requiring the use of a specialty courier. With experience in managing the logistics of over
storage and distribution of cold-chain products is a critical element of the clinical trial 7,500 clinical trials worldwide, we are the acknowledged experts in handling
process. Our expertise is of critical importance to ensuring the safe arrival of high value temperature-sensitive specimen and drug shipments. 24 x 7 x 365. Website:
shipments to sites. We provide: www.worldcourier.com
4 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
5. Main Conference Day One
Tuesday, December 8, 2009
7:30 Registration and Coffee • Evaluating your proposed clinical supply vendor’s necessary facility, equipment
and personnel infrastructure
8:15 Welcome Address and Chairperson’s Opening Remarks • Understanding the Importance of quality agreements
• Discussing best practice solutions approaches for a mutually beneficial working
Optimizing Your Clinical Supply Chain relationships and strategic alliances between client and clinical provider
Panelists:
8:30 Opening Keynote: Overcoming Key Inefficiencies Within Robert E. Holman
your Clinical Supply Chain Global Account Manager, Technology
• Pinpointing issues which are delaying your supply chain AstraZeneca
• Discussing the ideology of implementing lean principals within your clinical
supply chain, without increasing cost or damaging quality 2:00 Developing and Maintaining a Successful and Safe Vendor
• Learning from examples: An overview of a successfully modified clinical Relationship for Your Clinical Supplies
supply chain while displaying overcoming successful inadequacies within • Understanding strategic risk-management approach tools for vendor selection
the original processes and management
• Examining the options of working with a partner to speed up supply chain • Identifying and negotiating clear agreements to avoid pitfalls
• Establishing a personal relationship with your vendor for a unified approach
optimization
• Aligning a mutually-agreeable approach for both parties
Dick Winokur
• Discussing techniques for successful contract re-negotiation
Vice President, Clinical Supply Chain
Sanofi-Aventis Spencer Comtois
Manager, Vendor Relations, Clinical Supply Chain
9:15 Product Pooling: Creating Efficiencies Within your Clinical Schering Plough
Supply Chain
• Uncovering actual benefits of drug pooling and the most 2:45 Afternoon Networking Break
effective strategies
• Displaying technologies that support this approach to maximize clinical Investigating the Global Clinical Trials Regulatory Landscape
trial supply efficiency
• Examining novel supply labeling options to ensure efficient distribution 3:30 Complying with US Standards Regarding Customs Issues for
• Addressing difficulties in implementation – Case study example Importing Clinical Supplies
Linda Nichols • An overview of US importing and exporting shipping requirements
Global Demand Logistics, Pharmaceutical Development, R&D • Considering key pointers to ensure smooth logistic and distribution processes
• Understanding how to avoid detention of investigational material when
GlaxoSmithKline
importing to the USA
10:00 Morning Networking Break • Examining successful and unsuccessful case study examples of biopharma
company compliance
10:45 Understanding How and Why Global Clinical Supplies Aileen Suliveras
Effect Enrolment Director, Cargo Verification, Customs and Border Protection
• Examining the impact of deploying lean initiatives to decrease clinical Department of Homeland Security
supply overage
• Weighing up the importance of lean implementation with the bigger
Domenic Veneziano
Director, Import Operations & Policy
picture (enrolment and overage issues)
• Discussing solutions and strategies for overcoming unforeseen clinical trial
FDA
delays (FDA inspections etc)
• Risk assessment to operational efficiency to enrolment impact
4:15 Automated Clinical Trial Labeling Systems and Compliance
• Addressing overage issues and implementing IVRS
with FDA 21 CFR Part 11
• Examining automated clinical trial supply labeling techniques used to improve
Dawn Furey
efficiency and data integrity for randomized clinical trials
Associate Director, Research Operations • Evaluating the use of computers in the clinical trial supply labeling, inventory
Merck & Co.
management, and disposition
• Understanding the FDA requirements for compliance and scope of application
11:30 Optimal Planning for Clinical Supply of 21 CFR Part 11 as applied to your current systems
• Presenting techniques based on optimization approaches to align
Denise I. Webber
production and delivery schedule
• Optimizing warehouse and site storage inventory level, shipment size, and
President & Founder, Clinical and Regulatory Operations
D.I.Webber Consulting, LLC
minimize wastage of clinical materials
• Addressing the challenges of clinical trials supply chain planning
• Understanding factors affecting complexity of supply chain planning
5:00 Defining Import and Export Regulations, Procedures and
• Analysis of current approaches – simulation and optimization)
Strategies to Run Successful Global Clinical Studies
• Technique for optimal clinical trial supply chain planning
• Outlining different global import and export requirements to prevent the
oversight of key necessities
Vladimir Shnaydman • Complying with import and export rules to ensure the smooth running of
President
global clinical trials and on-time distribution
ORBee Consulting • Emphasizing the need of standardized global import and export requirements
to facilitate compliance
12:15 Networking Luncheon • Forecasting lead times to ensure accurate planning and to guarantee the
smooth operation of global trials
1:15 Panel Discussion: Analyzing Clinical Supplies Vendor • Outlining European shipping requirements to ensure efficient logistic and
Market: Choosing A Preferred Vendor Organization distribution processes
• Examining effective approaches for vendor selection and management as • Considering shipping times and delays for efficient forecasting of delivers and
well as achieving senior management buy-ins for vendor suggestions
clinical trial running times
• Understanding and reviewing the scientific background and capabilities of
Jessica Sonevytsky
tentative vendor organizations - Compiling a data set in order to rank and
Senior Regulatory Coordinator
risk assess potential vendor organizations
Merck & Co.
• Assessing the potential of a vendor organization’s global reach with
regards to clinical manufacture, supply channels, quality/regulatory
requirements
5:45 Chairpersons Closing Remarks and End of Day One
5 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
6. Main Conference Day Two
Wednesday, December 9, 2009
7:30 Registration and Coffee 12:15 Networking Luncheon
8:15 Welcome Address and Chairperson’s Opening Remarks Novel Storage, Packaging and Transport Solutions for
Accelerating Your Clinical Logistics
Effective Clinical Trial Logistics Risk Mitigation Strategies
1:15 Efficient and On-Time Shipment of Global Clinical
8:30 Building Risk Management into your Clinical Trial Logistics Supplies – Case Study
• Developing best practice risk management and joined up solutions-based • Creating an optimized clinical distribution model for maximum on time
thinking delivery performance
• Identifying and then measuring/assessing risks and developing strategies to
• Establishing large volume shipping containers for clinical materials
manage them • Overcoming customs controls within both the US and Australia
• Displaying a tried and tested risk management framework
• Displaying a successful joint strategic alliance between drug manufacturer
• Delivering beginning to end clinical logistics management lowering costs and
and freight forwarder
improving compliance and efficiency in all aspects of clinical trial supplies Jason C. Mattis
• Managing import/export requirements, coordination of drug supplies from
Principal Scientist, Sterile Product Manufacturing
manufacturers, distribution, drug return and destruction, and inventory GlaxoSmithKline
management
Gary Jones Jeff Sitzlar, Manager
Director, Clinical Supplies Business Development
Takeda FedEx Custom Critical
(Subject to final confirmation)
9:15 Due Diligence in Emerging Markets (EM)
• Examining emerging outsourced clinical trial markets 2:00 Interactive Global Distribution and Storage Strategies
• Understanding effective contract negotiations with EM partners Roundtable Discussions:
• Discovering how to structure and implement quality agreements with
After a jam-packed day of big picture keynotes, panel discussions, case
partners in EM studies, and presentations, the Clinical Trial Logistics gives you the chance to
• Displaying structure of the partnership for a positive outcome for both
meet and brainstorm with small groups of your peers during our interactive
parties roundtable discussions. This is a great opportunity to make valuable
• Addressing challenges in communication, time zones, and culture
• Evaluating options for CMO options in EM
contacts from your area of interest, and to deep-dive into the tricky details
• Displaying specific details on a current project in EM
that you may have missed in the course of the day’s sessions.
** Delegates are encouraged to bring their own data or study results for
Mark Walls discussion or submit them earlier to simon.curtis@iqpc.com
Director, Clinical Pharmacy Round Table Discussions include:
Human Genome Sciences • Setting up a distribution process – focusing on overcoming cold chain
challenges
10:00 Morning Networking Break • Complying efficiently with global regulatory bodies
• Discussing depot selection and management in emerging markets
10:45 How to Avoid Common Mistakes and Pitfalls for Clinical • Managing supply volumes and overage for individual sites
Trial Logistics Challenges in Emerging Countries • Reducing costs and maximizing ROI
• Identifying potential consequences of poor risk mitigation frameworks when
considering an overseas project and contingency planning to ameliorate 2:45 Afternoon Networking Break
them
• Balancing clinical product integrity, quality and cost
• Understanding the cultural challenges of your new marketplace and how to
3:30 Panel Discussion: Effectively Addressing Challenges of
Storage and Transportation of Clinical Supplies
ensure on time delivery • Becoming aware of regulatory requirements both domestically and
• Appreciating the High value of quality agreements and why it is essential to
internationally
collaboratively put them in place with your partner organizations •
Understanding successful handling of clinical supplies
• Examining techniques to retain and replace talented team members at home
• Overcoming import/export shipping challenges
and abroad • Developing and streamlining packaging, pre-qualification and
• Showcasing successful and unsuccessful overseas deployment of Clinical
transportation strategies
Supplies Logistics • Managing and working successfully with your partnering organizations –
Steve Jacobs Aligning an approach together
President, Global BioPharm Solutions and former CEO Panelists:
Bilcare Global Clinical Supplies Laurent Dhervilly
Senior Director, Pharm. Sciences Supply Chain Management Research
11:30 Factors to Consider When Deciding on Internal vs. External Pfizer
Clinical Manufacturing
• Self Evaluation of Internal capabilities: Capacity, equipment, systems, 4:15 Cold Chain Distribution and Logistics of Clinical Supplies –
technical expertise/core competencies and timing Case Study
• Project Development Cycle: Phase of project, probability of commercialization
• Stocking distribution depots with frozen medicinal supplies at -5° to -40 °
and probability of future formulation/process changes • Understanding when dry ice is too cold
• Optimization of entire clinical supply chain
• Examining engineered solution and gap
• KPI’s vs. Critical Success Factors (Long term vs. Short term views)
• Modified solution and operational testing
• Using external Clinical Manufacturing as beginning of commercial Secondary
• Evaluating performance during actual shipment from US to Brazil
Sourcing Process Alfred Mottram
• Managing organizational expectations/Involving the whole team
• Legal and Regulatory Implications: Time required for CDA’s/MSA’s, time
Associate Director, Drug Supply and Materials Management
Medarex
required for QA Audits, role of QP, quality agreements, filings and
import/exports 5:00 Chairpersons Closing Remarks and Close of Conference
Michael Colacino
Director, Clinical Manufacturing
Genzyme Drug & Biomedical R&D
6 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
8. International Quality & Productivity Center
REGISTRATION CARD 535 5th Avenue, 8th Floor
YES! Please
register me for:
Clinical Trials New York, NY 10017
Logistics TM
❑ Conference Only ❑ All Access*
❑ Conference + 1 workshop ❑ Master Class
❑ Conference + 2 workshops ❑ Workshop(s) ❑A ❑B ❑C
See Page 7 for pricing details.
Your customer registration code is:
When registering, please provide the code above.
Name__________________________________ Job Title ________________________
Organization____________________________________________________________
Approving Manager______________________________________________________
Address________________________________________________________________
City__________________________________State______________Zip____________
Phone________________________________Fax_______________________________
E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER:
❑ Please keep me informed via email about this and other related events.
1 Web: www.clinicaltrialslogistics.com
❑ Check enclosed for $_________ (Payable to IQPC)
2 Call: 1-800-882-8684
❑ Charge my __Amex __Visa __Mastercard __Diners Club
3 Email: info@iqpc.com
Card #__________________________________Exp. Date___/___ CVM code ______
4 Fax: 1-646-378-6025
Details for making payment via EFT or wire transfer can be found on
preceding page. 5 Mail: IQPC
535 5th Avenue, 8th Floor,
❑ I cannot attend, but please keep me informed of all future events. 18219.001/D/AL New York, NY 10017
Register by September 11th and SAVE UP TO $1,347
Presents
Clinical Trials
Logistics
TM
December 7-9, 2009
Philadelphia, PA
Maximizing Efficiency, Safety and Regulatory
Compliance Within your Clinical Supply Chain
